NCT04710407已完成1 期
A Phase 1, Single-center, Open-label Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma PK and lung penetration of SPR859 following multiple doses
研究概览
简要总结
To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
- •BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
- •Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
- •Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
- •Have suitable venous access for blood sampling
排除标准
- •History of seizure disorders
- •Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
- •Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
- •Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
- •Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)
- •Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
- •Difficulty breathing
- •Sore throat
- •New or recent loss of taste or smell
- •Nausea, vomiting or diarrhea;
- •Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
- •Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
- •Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:
- •White blood cell count < 3,000/mm3, hemoglobin < 11g/dL;
- •Absolute neutrophil count <1,200/mm3, platelet count <120,000/mm3;
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;
- •History of substance abuse or alcohol abuse
- •Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
- •Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
研究组 & 干预措施
TBPM-PI-HBr
Experimental
Healthy subjects meeting eligibility criteria will receive a total of five doses of TBPM-PI-HBr 600 mg orally every 8 hours.
干预措施: TBPM-PI-HBr (Drug)
结局指标
主要结局
Plasma PK and lung penetration of SPR859 following multiple doses
时间窗: Day 1 to Day 3
Plasma PK parameters will include the maximum concentration (Cmax), minimum concentration (Cmin), time to Cmax (tmax), and the terminal-phase half-life (t1/2).
次要结局
- Safety and tolerability, including clinically significant changes from baseline in clinical laboratory values(Day 1 to Day 10)
- Safety and tolerability, including ECG(Day 1 to Day 10)
- Safety and tolerability, including adverse events (AEs)(Day 1 to Day 10)
- Safety and tolerability, including physical examination(Day 1 to Day 10)
研究者
研究点 (1)
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